DiSCIS Clinical Core

DiSCIS 临床核心

基本信息

批准号：
8769788
负责人：
Nicholas J Van Wagoner
金额：
$ 40.21万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/8769788
关键词：
Adherence African American Alabama Appointment Bacterial Vaginosis Behavior Behavioral Biological Chlamydia trachomatis Clinic Clinic Visits Clinical Clinical Research Collection Communication Confidentiality Cost Savings County Couples Data Diagnosis Diagnostic Emotional Enrollment Ensure Ethics Event Fatigue Female Foundations Goals Health Healthcare High Prevalence Home environment Hour Intervention Knowledge Laboratories Maintenance Nylons Online Systems Paper Participant Patient Care Patients Performance Play Population Study Prevention Printing Procedures Protocols documentation Questionnaires Recovery Recruitment Activity Research Research Design Research Infrastructure Research Personnel Role Schedule Secure Sex Behavior Sexual Health Sexual Partners Sexually Transmitted Diseases Specimen Symptoms Syndrome Telephone Text Time Training Universities Urethritis Urine Vagina Visit Woman abstracting base cohort design diaries experience flexibility follow-up high standard human subject male men payment programs prospective research study sample collection screening sex success tool

项目摘要

DiSCIS Clinical Core Abstract The overarching goal of the Clinical Core is to engage, enroll, and retain participants in the Discharge Syndromes: Concordance and Interactions Study (DiSCIS) application. The investigators recognize the central role that human subjects play in this application and also the sensitivity of the information collected from study participants. All researchers will adhere to the highest level of ethical behavior in order to protect the physical and emotional wellbeing of the participants. The Clinical Core will support all projects outlined in the proposal through recruitment and performance of all clinic visits, including screening, initial, and subsequent study visits. Recruitment and all clinic events will be centralized at the Jefferson County Department of Health (JCDH) STD Clinic. In 2012, 16,119 patients (males=7,360 and females=8,759) received sexual health care at the JCDH STD Clinic. High prevalence of discharge syndromes including nongonococcal urethritis (about 25% of men), bacterial vaginosis (about 50% of women), and Chlamydia trachomatis (about 12% overall) are diagnosed and treated in this clinic. The JCDH STD Clinic and the University of Alabama (UAB) STD Program have an enduring partnership in STI research and STI-related patient care and a strong infrastructure already exists in this clinic for STI-related research. To maximize the success of the Clinical Core, we have assembled a clinical team with experience in designing, performing and completing longitudinal STI studies including couples studies. The specific aims for the Clinical Core are: (1) To centralize recruitment of men and women in regular sexual partnerships to create a cohort of participants to support all proposed projects, (2) To retain men and women in regular sexual partnerships for the duration of the study period, and (3) To collect accurate and complete participant information and biologics while protecting participant confidentiality. By supporting Projects 1-3, the Clinical Core will help to create new knowledge, advance diagnostic tools, and optimize therapy related to the most common discharge syndromes. The Clinical Core and its tight linkage to the Laboratory Core will ensure collection of quality specimens, efficiency and cost savings. The collective expertise of the Clinical Core team in clinical research study design, participant recruitment, and participant retention in prospective STI research including sexual dyad studies will provide a strong foundation for the success of all DiSCIS Projects while adhering to the highest standards of clinical research.

DiSCIS 临床核心摘要临床核心的总体目标是吸引、招募和留住出院参与者综合症：一致性和相互作用研究 (DiSCIS) 应用。调查人员认识到人类受试者在此应用中发挥的核心作用以及信息的敏感性从研究参与者收集。所有研究人员都将遵守最高水平的道德行为以保护参与者的身心健康。临床核心将通过招募和进行所有诊所就诊来支持提案中概述的所有项目，包括筛选、初次和随后的研究访视。招募和所有临床活动将在集中在杰斐逊县卫生部 (JCDH) 性病诊所。 2012年，16,119 患者（男性 = 7,360 名，女性 = 8,759 名）在 JCDH STD 诊所接受性保健护理。出院综合征的患病率很高，包括非淋菌性尿道炎（约 25% 的男性）、细菌性阴道病（约占女性的 50%）和沙眼衣原体病（约占总体的 12%）在此诊所进行诊断和治疗。 JCDH STD 诊所和阿拉巴马大学 (UAB) STD 该计划在性传播感染研究和性传播感染相关患者护理方面拥有持久的合作伙伴关系，并且拥有强大的实力该诊所已经存在用于性传播感染相关研究的基础设施。为了最大限度地取得成功临床核心，我们组建了一支在设计、执行和实施方面拥有丰富经验的临床团队。完成纵向性传播感染研究，包括夫妻研究。临床核心的具体目标是： (1) 集中招募具有定期性伙伴关系的男性和女性，以建立一个支持所有拟议项目的参与者群体，(2) 留住男性和女性在研究期间定期发生性关系，以及 (3) 收集准确的并完整的参与者信息和生物制剂，同时保护参与者保密性。通过支持项目 1-3，临床核心将有助于创造新知识、先进的诊断工具，并优化与最常见的出院综合症相关的治疗。临床核心及其与实验室核心的紧密联系将确保收集的质量标本，提高效率并节省成本。临床核心团队在临床方面的集体专业知识前瞻性性传播感染研究中的研究设计、参与者招募和参与者保留包括性二元研究将为所有 DiSCIS 项目的成功提供坚实的基础同时坚持临床研究的最高标准。